Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets

December 30, 2025 updated by: Shawn Gee, MD, Keller Army Community Hospital

Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction

The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are:

  • Examine the effects of KneeStim wear on cadets' post-operative gait
  • Examine changes in site-specific skeletal muscle mass
  • Examine the changes in patient-reported outcomes
  • Assess time to return to full duty
  • Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume)
  • Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture)

Participants will undergo body composition analysis, MRI, strength testing, standard of care rehabilitation, gait analysis, and complete surveys. Participants will wear the KneeStim during their standard of care rehabilitation visits for the first 5 weeks post-operative, and throughout daily tasks from 6-12 weeks.

Researchers will compare a control group (standard of care + KneeStim controlled low intensity) to an experimental group (standard of care + KneeStim flexible intensity) to assess the aims previously mentioned..

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Anterior cruciate ligament (ACL) tears have a recovery time of nearly 6-12 months with operative treatment. While most service members return to full duty after ACL reconstruction, it is delayed by quadriceps activation, muscle weakness, and abnormal gait patterns. Neuromuscular electric stimulation devices are already being used in physical therapy to complement gains in muscle strength and size. The innovation of KneeStim, is that it can be used to stimulate knee muscles while the individual is engaging in their daily activities. This study looks at the effects of 12 weeks of post-operative use of the KneeStim on biomechanical function (gait) in United States Military Academy Cadets aged 17-27 years of age. The investigators hypothesize that using the KneeStim will accelerate normalization of the biomechanical function parameters of gait and thus return to full duty.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. United States Military Academy cadet between ages of 17-27 years
  2. Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction

Exclusion Criteria:

  1. Concomitant or prior high tibial osteotomy (HTO)
  2. Concomitant or prior cartilage restoration procedure
  3. Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)

  4. Contraindications to using the KneeStim device

    - Use of pacemaker, defibrillators, or other implanted electronic devices, as this may cause electric shock, burns, electrical interference, or death Unstable angina or decompensated heart failure Epilepsy or history of seizure disorder Pregnancy or planning to become pregnant (Self reported) Critical ischemia of lower limbs Moderate to severe dementia Altered sensation at the knee such that the user cannot feel a pinprick Undiagnosed pain syndromes

  5. Any meniscus tear precluding weight bearing for 6 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Standard of Care + KneeStim controlled low intensity
Low intensity range
Device: KneeStim
Participant will be randomized to either be in control or experimental group
Experimental: Standard of Care + KneeStim flexible intensity
Flexible to high intensity range
Device: KneeStim
Participant will be randomized to either be in control or experimental group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in gait post-operatively assessed by the KneeStimTM Device
Time Frame: 6 weeks;3, 6, 9, 12 months post-operative
Effects of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (femur sagittal angle, tibial sagittal angle, femur coronal angle, tibial coronal angle, femur and tibia coronal velocity)
6 weeks;3, 6, 9, 12 months post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in gait post-operatively assessed by 3D Motion capture
Time Frame: 3, 6, 9, 12 months post-operative
Kinetic and kinematic biomechanical data will be monitored throughout the return to run phases of rehabilitation in knee and hip joints (walking and running); changes in gait speed (walking and running); changes in join angle range of motion (walking and running); changes in stride length (walking and running)
3, 6, 9, 12 months post-operative
change in gait post-operatively assessed by force plate instrumented treadmill
Time Frame: 3, 6, 9, 12 months post-operative
Ground reaction forces will be recorded simultaneously with the motion capture system via force plates on an instrumented treadmill to determine force output between limbs during walking and running trials.
3, 6, 9, 12 months post-operative
change in muscle volume assessed by MRI
Time Frame: pre-operative, 3, 6, 9, 12 months post-operative
Summation of the cross-sectional area and volumetric measurements
pre-operative, 3, 6, 9, 12 months post-operative
ACL graft healing assessed by MRI
Time Frame: pre-operative, 3, 6, 9, 12 months post-operative
Signal intensity will be used to monitor tissue quality throughout healing process
pre-operative, 3, 6, 9, 12 months post-operative
Change in isometric muscle strength assessed by CSMi HUMAC NORM
Time Frame: 3, 6, 9, 12 months post-operative
Rate of torque development (in ms) over time.
3, 6, 9, 12 months post-operative
Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS)
Time Frame: pre-operative, 3, 6, 9, 12 months post-operative
The KOOS is a self-reported outcome measure assessing the patient's perspective about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, activities of daily living, function in sports/recreation, and quality of life. A likert scale is used and all items have five possible answers ranging from 0 (no problems) to 4 (extreme problems). The five subscale scores are calculated as the sum of the items for each subscale. Scores are then transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
pre-operative, 3, 6, 9, 12 months post-operative
Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
Time Frame: pre-operative, 3, 6, 9, 12 months post-operative
The IKDC is a self-reported outcome measure that assesses knee disability and function before and after treatment. It consists of 18 items that measure symptoms, function, and sports activity. Response types include 5-point Likert Scales, 11-point Likert scales, and dichotomous "yes-no" responses.
pre-operative, 3, 6, 9, 12 months post-operative
Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29)
Time Frame: pre-operative, 3, 6, 9, 12 months post-operative
PROMIS-29 is a self-reported outcome measure assessing for the patient's pain intensity. It is a 28-item questionnaire, which includes 7 subscales of four items each: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. A likert scale is used for all domain response scales, however they vary in responses.
pre-operative, 3, 6, 9, 12 months post-operative
Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE)
Time Frame: pre-operative, 3, 6, 9, 12 months post-operative
Participants will provide a numerical rating from 0 (least normal) to 100 (most normal) of the perceived improvement in knee health in relation to their pre-injury baseline.
pre-operative, 3, 6, 9, 12 months post-operative
Change in knee function assessed by the Marx Activity Rating Scale (MARS)
Time Frame: pre-operative, 3, 6, 9, 12 months post-operative
MARS includes 4 items that assess the frequency of running, cutting, decelerating, and pivoting based on the subjects "healthiest and most active state in the past year". Each item is scored on a 5-point ordinal scale ranging from 0 (less than 1 time in a month) to 4 (4 or more times in a week), and the total scale score is obtained by summing the individual items' scores (range, 0-16). A higher score indicates more functional demand on the knee joint and potentially a higher risk of injury.
pre-operative, 3, 6, 9, 12 months post-operative
Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL)
Time Frame: pre-operative, 3, 6, 9, 12 months post-operative
The questionnaire consists of 32 equally weighted questions that are answered using a 100 mm visual analog scale and is scored of 100. It comprises 5 domains, including (1) symptoms and physical complaints (5 items); (2) work-related concerns (4 items); (3) recreational activity and sport participation or competition (12 items); (4) lifestyle (6 items); and (5) social and emotional (5 items).
pre-operative, 3, 6, 9, 12 months post-operative
Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI)
Time Frame: pre-operative, 3, 6, 9, 12 months post-operative
The 9-item UWRI assesses running ability following a running related injury, with the maximum score of 36 indicating a return to preinjury running ability.
pre-operative, 3, 6, 9, 12 months post-operative
Time to return to full duty
Time Frame: 12 months post-operative
Measured by the time from post-operative timepoint to time of full clearance for military tasks
12 months post-operative
Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA)
Time Frame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Skeletal muscle mass will be measured (in kg) to monitor rate of muscle hypertrophy/atrophy over rehabilitation timeline.
pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA)
Time Frame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Muscle mass, bone mass, and body fluid (kg/m2) will be measured to contribute to Body Mass Index (BMI) scores.
pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA)
Time Frame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Fat mass (kg/m2) will be measured to contribute to body mass index (BMI) scores.
pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS)
Time Frame: Weekly from 1-week post-operative until 3 months; monthly from 4-12 months
Will measure average knee pain over a given timeframe from 0 to 10 cm visual analogue scale where 0 cm equals no pain and 10 cm indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
Weekly from 1-week post-operative until 3 months; monthly from 4-12 months
Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring peak isometric knee extensor torque.
Time Frame: At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.
Peak isometric extensor torque (nm/kg).
At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.
Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring knee extensor rate of torque development.
Time Frame: At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.
Rate of torque development (nm/s)
At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Keller Army Community Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Technology Enterprise Consortium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shawn M Gee, MD, Keller Army Community Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KACH.2023.0067
  • 23KACH008 (Other Identifier: Keller Army Community Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all individual participant data (IPD) that underlie results in a publication.

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

request can be made to study contacts and will be reviewed by the study principal investigator and human research protections office.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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